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FDA In Limbo as User Fee Renewal Stuck on Capitol Hill
FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.
Salipro Biotech Obtains Patents in US and China for Direct Extraction of Membrane Proteins and Library Generation
Salipro has been granted patents in the United States and China for its proprietary technology to enable the development of therapeutics against challenging drug targets.
Charles River and Cure AP-4 Announce Manufacturing Collaboration
Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.
Avance Clinical Acquires C3 Research Associates
Avance Clinical’s acquisition of C3 Research Associates expands its CRO services to North America.
ElevateBio and the University of Pittsburgh Announce Creation of Pitt BioForge BioManufacturing Center
In partnership with the University of Pittsburgh, ElevateBio will open its next manufacturing center in the city.
Roche to Acquire Good Therapeutics for $250 Million
Roche’s acquisition of Good Therapeutics grants them rights to the company's conditionally activated PD-1-regulated IL-2 program.
SIRIO Enhances Company Strategy with Addition of Lonza’s Sara Lesina
SIRIO is enhancing its strategy for small and medium nutrition brands as Lonza’s Sara Lesina joins as GM in Europe.
Lynparza Approved in Great Britain
Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.
FDA Approves Novel ASMD Treatment from Sanofi
Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.
Lonza and Touchlight Enter mRNA Collaboration
Touchlight will expand Lonza’s end-to-end offering for mRNA manufacturing with an additional, differentiated source of DNA raw material.
Hovione Expands its Continuous Manufacturing Offering and Services
Hovione has expanded its drug product offering with a new manufacturing line dedicated to continuous tableting.
Novo Nordisk to Acquire Forma Therapeutics for $1.1 Billion
Novo Nordisk’s $1.1 billion acquisition of Forma Therapeutics is intended to expand its sickle cell and rare blood disorder portfolio.
FDA Authorizes Bivalent COVID-19 Boosters
FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.
Bio-Rad Launches Anti-Evolocumab Antibodies
Bio-Rad’s new antibodies are designed to develop highly selective pharmacokinetic (PK) and anti-drug antibody (ADA) assays for evolocumab and its biosimilars.
Roche Launches Digital PCR System
Roche’s Digital LightCycler System is designed to aid in diagnostics for cancer, genetic disease, and infection.
Lonza Strengthens Micronization Portfolio with the Introduction of X-Ray Powder Diffraction
Lonza has introduced X-ray powder diffraction capability at its Monteggio, Switzerland site.
Forecyte Bio and Cytiva to Collaborate on Cell and Gene Therapy Manufacturing and Development
Forecyte Bio and Cytiva will team up to accelerate the development and manufacturing of cell and gene therapies.
Emerson Opens Gas Analysis Solutions Center in Scotland
Emerson’s new gas analysis solutions center, located in Cumbernauld, Scotland, intends to help plants meet sustainability goals.
Thermo Fisher Scientific Opens Viral Vector Manufacturing Site in Massachusetts
Thermo Fisher Scientific’s new 300,000 ft² facility, located in Plainville, Mass., will specialize in manufacturing viral vectors.
NIH-Funded Scientists Develop Mouse Embryo Model That Generates Neural Tubes
Scientists have developed a mouse model that could be a promising model system for research into factors affecting mammalian embryonic development and disease.
MHRA Grants Novavax COVID-19 Vaccine Expanded Conditional Marketing Authorization
Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.
Canvax Releases New Inorganic Pyrophosphate
Canvax’s new inorganic pyrophosphate is designed for in-vitro transcription reactions.
Revisions to Annex 1 Officially Published
The European Union publishes long-awaited changes to Annex 1.
Moderna Files Suit Against Pfizer and BioNTech
Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.
Watson-Marlow and Franz Ziel GmbH Launch Cellefill
Watson-Marlow and Franz Ziel GmbH have launched a new integrated solution to fast-track cell, gene, and biological therapies.
ChargePoint Technology Acquires PuroVaso
ChargePoint Technology has acquired single-use container company PuroVaso.
Anthony Fauci to Step Down in December
Anthony Fauci announced that he plans to step down as Director of the National Institute of Allergy and Infectious Diseases in December 2022.
European Commission Approves Bevacizumab Biosimilar from Celltrion Healthcare
The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.
Grand River Aseptic Manufacturing Completes Phase II of Facility Expansion
Grand River Aseptic Manufacturing has completed phase II of its facility expansion with the installation of two new sterile filling lines.
ProBioGen Executes Master Service Agreement with NextPoint Therapeutics
ProBioGen will collobarate with NextPoint Therapeutics to develop and manufacture its lead antibody candidate.